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Идёт набор NCT06487780

Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

Без фазы С лечением Diabetic Foot Diabetic Foot Ulcer Foot Ulcer, Diabetic Foot Wound

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lifestyle-focused Occupational Therapy Intervention, Education.
Кому может быть актуально
Состояния в реестре: Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Foot Wound. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study

Обзор

People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.

Подробное описание

Diabetic foot ulcers (DFUs) are a significant complication of diabetes, responsible for 80% of lower extremity amputations in the United States and posing a substantial burden on patients and society. Despite treatment, up to 23% of DFUs remain unhealed at 12 months, with recurrence rates of 40% within a year and 65% within three years. Proper offloading of foot pressure and glucose control is crucial for preventing recurrent DFUs, especially in cases of neuropathy. While standard clinical practice includes patient education and therapeutic footwear prescription, adherence to offloading treatment often falls short due to non-medical factors such as insufficient understanding and difficulties integrating offloading into daily routines. To tackle these challenges, we propose a lifestyle-focused intervention, conducted by trained occupational therapist (OT), aiming at fostering consistent self-care habits and routines.The objective of this pilot trial is to evaluate the feasibility acceptability of a lifestyle-focused OT intervention for enhancing offloading treatment in high-risk individuals with a history of healed DFUs.

Вмешательства

  • Поведенческое Lifestyle-focused Occupational Therapy Intervention
    The proposed intervention, led by trained occupational therapists, will focus on establishing sustainable self-care routines. It will consist of approximately 12 biweekly sessions, each lasting about an hour on average. Therapists will customize session timing and duration based on participant needs.
  • Другое Education
    Participants in the education group will receive standardized education materials on diabetic foot ulcers (DFUs), foot care, and offloading treatment to prevent foot ulcer recurrence.

Первичные конечные точки

  • Numbers of participants who have completed the study [Срок оценки: 6-month]
Вторичные конечные точки (4)
  • Numbers of participants with diabetic foot ulcer recurrence [Срок оценки: 6-month]
  • Numbers of participants who report satisfaction with the program [Срок оценки: 6-month]
  • Number of participants with diabetes distress [Срок оценки: 6-month]
  • Participant's Quality of Life [Срок оценки: 6-month]

Критерии участия

Критерии включения

  • Age >= 21 years
  • Healed diabetic foot ulcer within the past twelve months
  • Able to walk independently (use of a cane is acceptable)

Критерии исключения

  • Current active diabetic foot ulcer
  • History of amputation beside toe or part of the foot
  • Non-ambulatory at baseline
  • Self-reported deafness/blindness.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 3 центра
  • Rancho Los Amigos National Rehabilitation Center — Downey
  • Keck Hospital of USC — Los Angeles
  • Los Angeles General Medical Center — Los Angeles

Публикации

  • Pyatak EA, Carandang K, Rice Collins C, Carlson M. Optimizing Occupations, Habits, and Routines for Health and Well-Being With Lifestyle Redesign(R): A Synthesis and Scoping Review. Am J Occup Ther. 2022 Sep 1;76(5):7605205050. doi: 10.5014/ajot.2022.049269. PMID 36053733
  • Pyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337 PMID 29351961

Идентификаторы

NCT: NCT06487780 · APP-24-03267

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗